Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of the Oncolytic HSV1 MVR-C5252

Part of paid clinical trials in New York, New York.

Sponsor
Duke University
Study ID
NCT06126744
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Recurrent High Grade Glioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MVR-C5252 — BIOLOGICAL
    MVR-C5252 is a genetically modified next generation oncolytic herpes simplex virus 1 (oHSV1) with an active domain of human IL-12 and Fab fragment of anti-PD-1 antibody. This is a Phase 1 open label study designed to determine the safety and tolerability of MVR-C5252. The dose-escalation portion of the study will be conducted in 4 stages to evaluate the safety of infusion and determination of the MTD/RP2D followed by efficacy assessment.

Study Details

This is a Phase 1 open label study designed to assess the safety and tolerability of the oncolytic herpes simplex virus 1 (oHSV1) study drug, MVR-C5252, administered intratumorally by convection-enhanced delivery (CED) in patients with recurrent high-grade glioma. Once the safety and maximum tolerated dose (MTD) is established in the dose escalation portion of the trial, a dose expansion cohort at the recommended phase 2 dose (RP2D) in patients with isocitrate dehydrogenase (IDH) wildtype recurrent glioblastoma (GBM) will evaluate preliminary efficacy of the study drug.

Key Dates

Start date
Jun 11, 2024
Status verified
Apr 2026
Primary completion
Dec 1, 2027
Completion
Dec 1, 2028

Study Design

Enrollment
51 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: MVR-C5252
    Open label single arm infusion of MVR-C5252, genetically engineered type 1 oHSV (oncolytic herpes simplex viruses) into the tumor via Convection-enhanced delivery (CED) a modality that can bypass the BBB (Blood Brain Barrier), allowing the intracranial delivery through the BBB and avoiding systemic toxicities.

Primary Outcome Measure

Stage 1: Proportion of patients with dose-limiting toxicity (DLT) during the single infusion [ Time Frame: Day 1 of treatment until 28 days post first infusion ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Memorial Sloan KetteringNew YorkNew York10065
Christian Grommes, MD
[email protected]
212-610-0344
Lauren Schaff, MD
[email protected]
212-610-0485
Duke UniversityDurhamNorth Carolina27750
Mustafa Khasraw, MD
[email protected]
919-681-8838
BTC Triage Help
[email protected]
919-684-5301

Find similar trials in New York, NY

By research site
Memorial Sloan Kettering· New York, NYDuke University· Durham, NC

Related Studies